Vitamin D and Omega-3 Inhibit Metabolic Syndrome
NCT01326442 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2013-06-13
Summary
The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease. Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and blood collected at weeks 0 and 16.
Conditions
Interventions
- OTHER
-
low glycemic diet
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
- DIETARY_SUPPLEMENT
-
vitamin D omega-3
2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.
Sponsors & Collaborators
-
University of Guelph
lead OTHER
Principal Investigators
-
Kelly A Meckling, PhD · University of Guelph
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- Canada
Study Locations
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